Predetermined change control plan (PCCP)

A PCCP lets a manufacturer make the changes it describes without a new 510(k) or PMA supplement, as long as the changes follow the authorized plan. It is submitted and authorized with the marketing submission, and changes outside it follow the normal rules.

The documentation describing what modifications will be made to a device and how the modifications will be assessed. The modifications described in the PCCP include device modifications that would otherwise require a PMA supplement or new premarket notification. The PCCP includes a Description of Modifications, Modification Protocol, and Impact Assessment. PCCPs for AI-DSFs are the focus of this guidance.

FDA guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025), Section IV, Definitions